AMY-TAVI: Impact of Amyloidosis on TAVI Patients

Sponsor

Javier López Pais (Other)

Overall Status

Unknown status

CT.gov ID

NCT03984877

Collaborator

(none)

320

Enrollment

Location

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To analyze the prevalence and impact on the prognosis of amyloidosis due to transthyretin in patients with severe aortic stenosis who undergo percutaneous aortic valve implantation.

Condition or Disease	Intervention/Treatment	Phase
Valve Stenoses, Aortic Amyloidosis Cardiac	Diagnostic Test: Diagnosis of amyloidosis

Detailed Description

Type and design of the study: Multicentric, prospective cohort, observational.

Number and characteristics of the patients: 321 patients to whom TAVI has been implanted due to severe degenerative AS.

Duration of the study

Recruitment period: All consecutive patients undergoing a non-invasive diagnostic study of amyloidosis (scintigraphy with technetium pyrophosphate99 and blood protein electrophoresis) will be recruited before discharge, in centers with proven experience, will accept non-invasive diagnosis with resonance) and have an implanted percutaneous aortic prosthesis for severe aortic stenosis.
Follow-up period: clinical and echocardiographic follow-up will be carried out before discharge, in consultation at three, six, twelve and twenty-four months.

Inclusion: 1 year

Follow up: 2 years

Data analysis: 6 months

Total: 3 years and 6 months

Events

Main event: cardiovascular events (cardiovascular death, stroke, infarction)
Secondary events: death from any cause, readmission due to heart failure, pacemaker implantation, functional class evaluation

Countries and participating centers: Various Spanish and international centers will be invited to participate.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

320 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Amyloidosis TAVI patients with diagnosis of amyloidosis	Diagnostic Test: Diagnosis of amyloidosis Scintigraphy and protein electrophoresis
Non-Amyloidosis TAVI patients without diagnosis of amyloidosis	Diagnostic Test: Diagnosis of amyloidosis Scintigraphy and protein electrophoresis

Arm

Intervention/Treatment

Amyloidosis

TAVI patients with diagnosis of amyloidosis

Diagnostic Test: Diagnosis of amyloidosis

Scintigraphy and protein electrophoresis

Non-Amyloidosis

TAVI patients without diagnosis of amyloidosis

Diagnostic Test: Diagnosis of amyloidosis

Scintigraphy and protein electrophoresis

Outcome Measures

Primary Outcome Measures

Mortality [1 year]
Survival after TAVI of patients with amyloidosis

Secondary Outcome Measures

Pacemaker requirements [15 days]
Number of patients with amyloidosis who received pacemaker after TAVI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aortic valve replacement with a percutaneous prosthesis due to severe aortic stenosis after evaluation by the Heart Team.
Ability to understand and sign informed consent.
They do not meet any of the exclusion criteria.